FDA Device Establishment Registration & Listing

How this source shows up on Fonteum.

Aggregate device-firm reference, keyed to the registered establishment (name-normalized for a deferred Open Payments cross-link). Fonteum surfaces the establishment identity and type; the entity-graph link is held for ambiguous matches, never written.

Research and data questions this source supports.

• 01Enumerate the medical-device firms registered to manufacture or distribute devices, by establishment type and location.
• 02Build a device supply-chain map keyed to the registered establishment and FEI number.
• 03Cross-reference a device firm's registration against its recall enforcement history.
• 04Power a research surface on device-establishment density by state and country.

Dataset size: 24,809 registered establishments (2026-06-14 snapshot)

Per-field display contract.

Every field below has a `display_allowed` flag in the §94 provenance schema. Write-locked fields are captured to provenance for audit but never rendered on profile pages.

What we can’t infer from this source.

• Tier-1 — aggregate research context only; never rendered on individual provider profiles.
• Firm-keyed by registration number; firm name is name-keyed, with the entity-graph cross-link deferred.
• Registration is a facility-administration record; it is not a measure of device quality or safety.
• openFDA omits empty fields; some registrations carry sparse type or expiry detail.

Authority, license, refresh cadence.

What the source allows.

openFDA data is CC0 public domain. No API key is required for bulk downloads; attribution to openFDA is the courtesy ask. Fonteum pulls the device registration partition and attests each snapshot.

What a single field looks like in the graph.

A worked example. Every field surfaced from this source carries this shape of provenance line — source · last checked · display rule · confidence (when applicable).

Official API, bulk download, and Fonteum endpoints.

Common questions about FDA Establishment.

What is the FDA device establishment registration dataset?

It is the openFDA feed of firms registered to manufacture or distribute medical devices — registration number, FEI number, firm name, establishment type, and location. Registration is required under FDA's device regulations; the feed is the public listing of registered establishments.

Does registration mean a device is safe or approved?

No. Establishment registration is an administrative record that a firm registered a device facility. It is not a clearance, an approval, or a measure of device quality or safety — those are separate FDA processes.

Where can I download this data?

From the openFDA device registration/listing API (api.fda.gov/device/registrationlisting.json) and bulk downloads at open.fda.gov. openFDA data is CC0 public domain — free to use and redistribute with attribution, no API key required.

Is a registered establishment linked to a provider?

No. Establishments are firm-keyed by registration number; the firm name is recorded by name. There is no NPI, and the Open Payments cross-link is deferred — ambiguous matches are held, not written.

How fresh is the data?

openFDA republishes the device registration partition roughly weekly; Fonteum re-pulls on snapshot publication. As of the 2026-06-14 snapshot, Fonteum holds 24,809 registered establishments.

Where this source already shows up.

Related sources in the graph

• /sources/fda-enforcement-reports →
• /sources/fda-drugs-at-fda →
• /sources/fda-drug-ndc →

• /sources → The full source library — every dataset Fonteum cites.
• /data-provenance → The provider graph — pipeline diagram, source-family clusters, field-level provenance examples, display rules.
• /methodology → Network-wide sourcing, refresh cadence, and corrections policy.
• /editorial-policy → Independence, sourcing, conflicts, corrections, retractions.